Patent Law and the Supreme Court: Patent Certiorari Petitions Denied in 2013

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WilmerHale compiles lists of certiorari petitions that raise patent-law issues. This page contains a consolidated list of denied petitions for this year, organized in reverse chronological order by date of certiorari petition.

Rule 56(a), Federal Rules of Civil Procedure, permits a grant of summary judgment only if “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” The questions presented for review are:

Whether a United States Court of Appeals, in summarily affirming an internally inconsistent summary judgment that is directly contradicted and discredited by the district court's own fact-findings, has so far departed from the accepted and usual course of summary judgment proceedings as to call for an exercise of this Court's supervisory power? See Sup. Ct. R. 10(a).

Whether an internally inconsistent summary judgment—directly contradicted and discredited by the district court's own fact-findings—violates the right to trial by jury secured by the Seventh Amendment to the United States Constitution?

Whether an internally inconsistent summary judgment—directly contradicted and discredited by the district court's own fact-findings—violates the guarantee of due process in federal courts secured by the Fifth Amendment to the United States Constitution?

Whether the mere act of omitting purportedly material information during a patent prosecution, without separate proof of intent to deceive the Patent and Trademark Office, can constitute clear and convincing evidence sufficient to support a finding of inequitable conduct.

Whether a corporation can be found liable for inequitable conduct in the absence of a finding of inequitable conduct by any of its officers, employees or agents.

In Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060 (2011), this Court held that, to be liable under a “willful blindness” theory of intent, “(1) the defendant must subjectively believe that there is a high probability that a fact exists and (2) the defendant must take deliberate actions to avoid learning of that fact.” Id. at 2070. The Court explained that “willful blindness” is a rigorous standard that “surpasses recklessness and negligence.” Ibid. In Safeco Insurance Co. of America v. Burr, 551 U.S. 47 (2007), the Court held that a defendant cannot be found to have committed a violation under the lesser “recklessness” standard if its actions were consistent with an understanding of legal requirements that was “not objectively unreasonable,” “whatever [its] subjective intent may have been.” Id. at 70 & n.20. The question presented is:

Whether a defendant may be held liable under the “willful blindness” standard where its actions were consistent with an understanding of relevant legal requirements that was not objectively unreasonable.

Whether the Federal Circuit upheld a patent infringement verdict of more than $100 million by failing to apply the obviousness standard set forth in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), and reverting instead to its pre-KSR “teaching, suggestion, or motivation” test.

In Microsoft Corp. v. i4i Ltd., 131 S.Ct. 2238 (2011), this Court held that 35 U.S.C. § 282 requires fact finders in patent infringement cases to “determin[e] whether an invalidity defense has been proved by clear and convincing evidence.”131 S.Ct. at 2251. Three Justices also wrote separately to “emphasiz[e]” that the clear and convincing standard “applies to questions of fact” underlying invalidity, “not to questions of law” like whether an invention is non-obvious within the meaning of the Patent Act. Id. at 2253 (Breyer, J., concurring, joined by Scalia and Alito, JJ.). Consistent with centuries of Anglo-American law and multiple decisions of this Court, and to ensure that “inventions will not receive legal protection where none is due,” the concurring Justices urged district courts to “separat[e] factual and legal aspects of an invalidity claim” by “using instructions … that help the jury make the distinction.” Ibid.

Here, over petitioner's objection, the district court refused to cabin the clear and convincing standard to the jury's fact-finding, instead permitting that heightened standard to infect legal questions concerning invalidity. The district court then simply adopted the jury's verdict with no analysis of the ultimate legal questions. Without explanation, and despite full merits briefing and a lively oral argument, the Federal Circuit affirmed by summary disposition.

The question presented is whether, following i4i, a district court may ignore the fact/law distinction and in so doing instruct a jury to apply the heightened “clear and convincing” standard not only to disputed factual aspects of an invalidity claim, but also to the legal aspects of such a claim—including the ultimate question of a patent's invalidity?

The Federal Circuit's opinion below, for the first time in American jurisprudence, invalidated a patent based on a prior “invention” that provided no benefit to the public, because the prior inventor concealed how to make the invention, did not commercialize it, and did not apply for a patent. The Federal Circuit based its holding on a distinction between “process” and “product” patents that does not exist in the plain language of the relevant statute, 35 USC § 102. Did the Federal Circuit err in interpreting § 102(g)(2) to allow non-enabling disclosures to invalidate product patents, a result that will create significant uncertainty in litigation involving product patents and penalize patent holders who publicly shared their inventions?

Section 337 of the Tariff Act of 1930 permits the International Trade Commission to exclude from entry into the United States an article that infringes a valid and enforceable patent. Under what is known as the “domestic industry” requirement, however, it may do so only when a complainant establishes that there is “an industry in the United States, relating to the articles protected by the patent.”

Respondent InterDigital asserted that petitioner Nokia violated section 337 by importing cellular handsets into the United States that allegedly infringed InterDigital's patents. After a five-day evidentiary hearing, a judge concluded that no infringement had occurred. In a divided opinion, the Federal Circuit, employing de novo review, concluded that the patent claims had been erroneously construed and reversed the non-infringement determination. The court also held that “licensing alone” is sufficient to satisfy the domestic industry requirement. In denying rehearing, the panel majority reiterated that licensing alone satisfies the domestic industry requirement as long as the patent concerns “the article that is the subject of the exclusion proceeding.” The questions presented are:

Whether the “domestic industry” requirement of section 337 is satisfied by “licensing alone” despite the absence of proof of “articles protected by the patent.”

Whether underlying factual determinations in a patent claim construction ruling should be subject to deferential review by the Federal Circuit.

Did the Court of Appeals for the Federal Circuit err in restricting district courts' equitable discretion in evaluating patent unenforceability, contrary to this Court's precedent in Keystone Driller, Hazel-Atlas, and Precision Instrument, by applying a rigid test that (a) forecloses district courts from considering the entire circumstantial record; and (b) precludes district courts from granting equitable remedies where a patent applicant has violated the PTO's duty of candor.

The Patent Act has long forbidden falsely marking and advertising unpatented articles as patented. The false marking statute, 35 U.S.C. § 292, also long provided a qui tam cause of action for any member of the public to pursue violators on the government's behalf. In June 2009, Petitioner filed such an action against Respondent. In September 2011, more than two years after Petitioner filed this case, Congress passed the Leahy-Smith America Invents Act (AIA) that contained amendments to the false marking statute. One such amendment eliminated qui tam standing for members of the public to bring false marking claims. The AIA applied its changes to the false marking statute retroactively and, as a result, the district court dismissed Petitioner's case because Petitioner no longer had standing under the retroactively amended version of the statute. The Court of Appeals summarily affirmed.

Does the retroactive application of the AIA's changes to the false marking statute to this case violate Petitioner's Due Process under the Fifth Amendment?

The Federal Circuit reversed the District Court and held the claims of Intema's patent ineligible under 35 U.S.C. §101 by misapplying Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012) in a manner that creates erroneous, rigid rules for determining patent ineligibility in cases involving laws of nature. If the Judgment of the Federal Circuit is not reversed, it will have the practical effect of rendering most diagnostic, screening and personal medicine tests unpatentable.

The questions presented by this Petition for a Writ of Certiorari are:

the inventive concept is in the selection, combination and timing of the data collected in the data-gathering steps; and/or

the final step is calculating a new and useful test result from data collected by novel data-gathering steps, but does not involve a physical activity?

Did this Court in Mayo establish the rigid rules for patent eligibility of claims involving a law of nature found by the Federal Circuit, namely that:

data-gathering steps, even if they include new and non-obvious combinations of known steps, may not be considered all or part of the “inventive concept” that ensures that the patent is significantly more than the natural law itself; and/or

a claimed method that provides test results that determine a course of action must include a final step that involves physical activity?

Should the determination of patent eligibility under Section 101 be based on a Markman claim construction as the District Court did, as opposed to an inaccurate paraphrase of the claim as used by the Federal Circuit?

The Federal Circuit reversed a Trial Court's denial of sanctions based on its de novo finding that the Plaintiff's patent case was frivolous in violation of Fed. R. Civ. P. 11. In its ruling, the Federal Circuit gave no deference to the Trial Court findings and created a formalistic rule that evidence of non-trivial settlements cannot be considered to determine objective reasonableness of the lawsuit under Rule 11, which conflicts with several other circuits.

The Federal Circuit found that settlement evidence “has no place in the Rule 11 analysis,” which ignores the widely-recognized relevance such evidence has in showing the views of objective litigants (e.g. settling Defendants) as to whether the underlying lawsuit was reasonably calculated to elicit a favorable outcome. Petitioner respectfully requests that the Supreme Court grant this Petition for a Writ of Certiorari on the following questions.

Whether the Federal Circuit erred in creating a de facto rule that past non-trivial settlements cannot be considered in objective reasonableness determinations for Fed. R. Civ. P. 11 sanctions, which is a departure from precedent in at least four other Circuits finding that settlements can be considered for objective reasonableness and Rule 11 analysis.

Whether the Federal Circuit erred in finding an abuse of discretion by a Trial Court's consideration of non-trivial settlement evidence in a sanctions determination when such evidence is relevant in demonstrating the views of objective litigants (e.g., settling Defendants) as to whether the Plaintiff's case was reasonable.

Whether the Federal Circuit's lower level of deference given to Trial Court determinations, as shown by its extraordinary reversal rates in patent cases and its adoption of an expanded de novo standard of review, conflicts with the higher level of deference shown to Trial Court determinations by the other circuit courts, especially those courts reviewing Trial Court sanctions determinations.

Whether the Federal Circuit erred in making a de novo determination that the Plaintiff's entire case was “frivolous” without analyzing all the relevant facts normally considered when reviewing the merits of a patent lawsuit, including: (1) the prior Federal Circuit precedent supporting the objective reasonableness of Plaintiff's claim interpretations, (2) the Plaintiff's alternate infringement theories embodied in doctrine of equivalents infringement claims, (3) disagreements among the various Defendants (and with the Plaintiff) regarding the contested claim construction, and (4) the technical and patent law expert opinions supporting the objective reasonableness of the Plaintiff's case.

The “enablement” provision of the Patent Act, 35 U.S.C. § 112(a), states that a patent “shall contain a written description of the invention *** in such full, clear, concise, and exact terms as to enable any person skilled in the art *** to make and use the same.” The Federal Circuit's cases are in conflict over the meaning and application of this core patentability requirement. The patent at issue claims a collapsible prosthetic valve attached to a stent “for implantation in a body channel.” The specification describes the claimed invention as directed primarily to a valve implanted by catheter in the human heart. Yet the specification does not disclose how to make a valve that is small and stable enough to achieve that purpose. Engineers attempting to apply the patent could not make a valve suitable for human implantation despite many years of effort, and no experimental animal survived implantation for more than a few hours. The questions presented are:

Whether a claimed invention is enabled within the meaning of 35 U.S.C. § 112(a) where the patent does not describe how to make and use it and engineers could not do so despite years of effort.

Whether the Federal Circuit's holding that an injunction is presumptively warranted after a verdict of infringement conflicts with this Court's decision in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006).

Whether a court of appeals may refuse to decide if an appealed dismissal of a party for lack of jurisdiction was proper, and instead make rulings on the merits regarding that party including factual findings on issues not addressed by the district court without first establishing jurisdiction over that party.

Did the court of appeals err in conducting a de novo review of a summary judgment by not believing the declaration submitted by non-movant and by not drawing inferences in non-movant's favor?

After Respondents granted Petitioner ClearPlay, Inc. a license of their patent rights, Respondent Nissim Corp. told ClearPlay's business partners that the licensee's products (1) violated certain covenants of the parties' license agreement unrelated to the patents' field of use, (2) were accordingly “unlicensed,” and (3) therefore infringed on the licensors' patents.

Is a patent license an affirmative covenant not to sue, as held by the Federal Circuit and adopted by several other circuits, or does a license allow the licensor to threaten infringement suits, as held by the Eleventh Circuit?

Do federal patent laws preempt state-law business-interference claims when the veracity of a licensor's assertions that its products were “unlicensed” can be determined by looking to the terms of the license agreement without regard to any issues of patent law?

Whether the offer for sale and/or sale of a product that embodies a patented invention can directly infringe a method claim under 35 U.S.C. § 271(a)?

Whether the Federal Circuit has created an improper de facto rule precluding the use of circumstantial evidence to establish that one or more steps in a patented method have been performed for the purpose of demonstrating infringement?

The Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, created a safe harbor from liability for patent infringement. The statutory safe harbor provides that it shall not be an act of patent infringement to make or use a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” 35 U.S.C. § 271(e)(1). The safe harbor “allows competitors, prior to the expiration of a patent, to engage in otherwise infringing activities necessary to obtain regulatory approval” from the Food and Drug Administration (“FDA”). Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 671 (1990). In this case, the Federal Circuit held that the safe harbor immunizes respondents' use of petitioners' patented method in the course of post-approval manufacturing of respondents' drug for commercial sale, in direct competition with petitioners, during and throughout the life of petitioners' patent.

The question presented is:

Whether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempted from liability for patent infringement under Section 271(e)(1) as “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”

With respect to prior art public accessibility, the question presented is:
Whether the status of public accessibility of a reference to qualify as a prior art publication under 35 U.S.C. §102(b) for patent invalidation under 35 U.S.C. §103(a) must be shown with clear and convincing evidence?

On August 31, 2012, following oral argument on November 18, 2011, a majority of six of the Federal Circuit en banc rendered their judgment in the cases consolidated in Akamai Technologies, Inc. v. Limelight Networks, Inc. (reported at 692 F.3d 1301) on the question of the propriety and operation of the so-called “single-entity rule,” previously announced by a panel of the Federal Circuit in BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007) and elaborated upon in Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008). The “single-entity rule” is a doctrinal basis for the decision of non-infringement in the present case, in which a panel of the Federal Circuit rendered its opinion on November 5, 2012. The questions presented are:

Whether 35 U.S.C. § 271(a) by its own terms and without being extended imposes liability upon multiple independent parties who collectively perform the various steps of a patented method claim in the practice of the patented invention?

Whether the making, offering to sell, sale or use of a system which incorporates, or controls, or directs the practice of an entire method claim of a patented invention infringes the method claim under 35 U.S.C. §271(a)?

With respect to the distinction between the doctrine of equivalents and equivalents under 35 U.S.C. §112 ¶ 6, the question presented is: Whether a human action in the operation of an accused system that performs the same function as a means plus function element of a system claim cannot be an equivalent to that system claim element in determining infringement under the doctrine of equivalents?

With respect to substantial departure from the usual course of judicial proceedings in the lower courts, the questions presented are:

Whether the lower courts erred in affirming the sua sponte imposition by the district court of protection and ad hoc conditions of onerous travel upon a party seeking to compel compliance with requests for production?

Whether the Federal Circuit Panel erred in ruling that Voter Verified had on appeal waived its action for indirect infringement, where the district court had only ruled on the issue of direct infringement with summary judgment; and where the legal doctrine prevailing in the Federal Circuit during the pendency of this action precluded any finding of indirect infringement without a finding of liability for direct infringement.

Whether the Federal Circuit Panel erred in basing appellate holdings on misstatements of the undisputed evidence and misstatements of the holdings of the district court, thereby denying to the Petitioner due process of law guaranteed by Amendment V of the United States Constitution?

Whether the Federal Circuit Panel erred in failing to enter summary judgment for Voter Verified on the issues of infringement and invalidity presented with motions therefor in the district court?

With respect to prior art public accessibility, the question presented is: Whether the status of public accessibility of a reference to qualify as a prior art publication under 35 U.S.C. §102(b) for patent invalidation under 35 U.S.C. § 103(a) must be shown with clear and convincing evidence?

On August 31, 2012, following oral argument on November 18, 2011, a majority of six of the Federal Circuit en banc rendered their judgment in the cases consolidated in Akamai Technologies, Inc. v. Limelight Networks, Inc. (reported at 692 F.3d 1301) on the question of the propriety and operation of the so-called “single-entity rule”, previously announced by a panel of the Federal Circuit in BMC Resources, Inc. v. Paymentech, L.P.,498 F.3d 1373 (Fed. Cir. 2007) and elaborated upon in Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008). The “single-entity rule” is a doctrinal basis for the decision of non-infringement in the present case, in which a panel of the Federal Circuit rendered its opinion on November 5, 2012. The questions presented are:

Whether 35 U.S.C. § 271(a) by its own terms and without being extended imposes liability upon multiple independent parties who collectively perform the various steps of a patented method claim in the practice of the patented invention?

Whether the making, offering to sell, sale or use of a system which incorporates, or controls, or directs the practice of an entire method claim of a patented invention infringes the method claim under 35 U.S.C. §271(a)?

With respect to the distinction between the doctrine of equivalents and equivalents under 35 U.S.C. §112 ¶6, the question presented is: Whether a human action in the operation of an accused system that performs the same function as a means plus function element of a system claim cannot be an equivalent to that system claim element in determining infringement under the doctrine of equivalents?

With respect to substantial departure from the usual course of judicial proceedings in the lower courts, the questions presented are:

Whether the lower courts erred in affirming the sua sponte imposition by the district court of protection and ad hoc conditions of onerous travel upon a party seeking to compel compliance with requests for production?

Whether the Federal Circuit Panel erred in ruling that Voter Verified had on appeal waived its action for indirect infringement, where the district court had only ruled on the issue of direct infringement with summary judgment; and where the legal doctrine prevailing in the Federal Circuit during the pendency of this action precluded any finding of indirect infringement without a finding of liability for direct infringement.

Whether the Federal Circuit Panel erred in basing appellate holdings on misstatements of the undisputed evidence and misstatements of the holdings of the district court, thereby denying to the Petitioner due process of law guaranteed by Amendment V of the United States Constitution?

Whether the Federal Circuit Panel erred in failing to enter summary judgment for Voter Verified on the issues of infringement and invalidity presented with motions therefor in the district court?

Whether the conduct of the lower courts so far departed from the accepted and usual course of judicial proceedings and/or denied to the petitioner due process of law guaranteed by Amendment V of the United States Constitution in:

Failing to enter default under Rule 55(a), Fed. R. Civ. P.;

Refusing to permit discovery concerning the failure of the clerk of the district court to enter a default and the clerk's referral of the motion therefor to a magistrate judge;

Failing to consider the district court's own documentation showing (1) improper interference with the operation of the clerk of the district court related to the clerk's failure to enter default and referral of the motion therefore to a magistrate judge; and (2) improper acceptance by the magistrate judge of the referral of the motion for default to deny it as moot upon an unauthorized filing by the defaulting party;

Refusing to permit discovery or testimony in opposition to declarations filed in support of a claim of excusable neglect;

Denying the Petitioner's right to present evidence in opposition to declarations filed in support of a claim of excusable neglect.

Whether the Court of Appeals for the Federal Circuit may refuse to review a fully briefed challenge to a jury's finding of willful patent infringement solely because the trial court did not enhance damages based on the jury's finding, even where the finding of willfulness itself leads to serious, albeit non-pecuniary, reputational harms;

Where a prior art patent discloses every structural element of a patentee's claimed invention, and also discloses a device that performs the claimed invention's remaining functional element, does the patentee bear a burden of proving that the device disclosed in the prior art patent would not actually perform the claimed function in order to avoid a finding that the later claimed patent is invalid under 35 U.S.C. § 102; and

Where an alleged infringer has shown that the scope of coverage necessary for a patentee's claim to cover the accused technology for purposes of infringement under the doctrine of equivalents would also sweep broadly to cover a prior art patent, does the patentee bear any burden of showing that the broadened scope of the claim would not in fact cover the prior art?

Under 35 U.S.C. § 103(a), a claimed invention is patentable if it would not have been “obvious” at the time it was made to a person having ordinary skill in the art. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), this Court held that obviousness is determined by looking “to interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all to determine whether there was an apparent reason to combine known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. The question presented here is:

Whether the Federal Circuit effectively eliminated the standard articulated in KSR by substituting the trial court's own determination of “common sense,” a standardless and unpredictable standard.

Where patent litigation is pending in federal court, the patent-holding defendant sued the plaintiffs' attorney in state court for defamation and unfair practices for publishing an essay about the federal litigation, alleging an attempt to taint the jury pool and gain unfair advantage in the federal litigation, identifying the federal case numbers, and using the word “patent” 16 times:

Do state courts have subject-matter jurisdiction of defamation and unfair-practices collateral lawsuits against the attorney for opponents in federal-court patent litigation, which allege the attorney's actions related to the patent litigation?

Under what circumstances is a person who performs some of the steps of a patented method, in combination with another's performance of the remaining steps, liable for direct infringement of the patent?

Does Article III's grant of jurisdiction of “all Cases … arising under … the Laws of the United States,” implemented in the 'actual controversy' requirement of the Declaratory Judgment Act, §28 U.S.C. 2201(a), require the patent holder to have direct communication with the potential patent infringer before that infringer may sue to declare the patent invalid or not infringed?

Are a patent licensee's contract and tort claims against its licensor claims that arise under federal patent law such that they are within the exclusive jurisdiction of the federal courts when:

those claims depend upon proof of infringement of a claim of a licensed patent or patent application;

the patent license measures the allegedly breached obligations by reference to provisions of the federal patent laws and regulations governing practice before the United States Patent and Trademark Office; or,

the licensee's claims seek to impose duties upon licensed practitioners conducting patent prosecution before the United States Patent and Trademark Office?

In determining whether a patent license dispute arises under federal patent law and is within the exclusive jurisdiction of the federal courts, should the court consider the license and actual elements of proof necessary for the plaintiff to prevail on its claims?

Did the Federal Circuit have power to go outside the record to override the contrary factual findings of the United States Patent and Trademark Office and invalidate a patent solely based on its own unarticulated and unexplained view of “common sense”?

Whether the Federal Circuit erred in affirming a decision based on a definition of the term “Internet” for purposes of patent protection as consisting solely of a “public network” and not including private networks.

Whether the Federal Circuit erred in affirming a decision of the Board of Patent Appeals and Interferences based on grounds which were different from those found by patent examiners and which petitioner has therefore never had an opportunity to address or rebut.

Under the Patent Act, “a patent may not be obtained” if its subject matter would have been “obvious” when viewed in light of the prior art. 35 U.S.C. § 103. This statutory patentability standard invalidates any patent claim that would have been obvious in view of any prior art, regardless of the technology at issue. In recent years, and continuing even after this Court's decision in KSR Int'l v. Teleflex, Inc., 550 U.S. 398 (2007), the Federal Circuit has applied a restrictive “lead compound” test for determining the obviousness of pharmaceutical compounds, which limits the scope of the prior art against which the obviousness of pharmaceutical compounds are evaluated to one or more “lead compound[s],” on the ground that a “lead compound” is “a natural choice and “most promising” … “for further development efforts”. The question presented is whether the “lead compound” requirement is consistent with the statutory command that all obvious variations of the prior art be denied patent protection, given that there will be cases in which the structural similarity between the patented compound and a prior art compound, even if not a lead, rendered the patented compound obvious.

The Patent Act provides that “[a] patent may not be obtained … if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.”35 U.S.C. § 103(a). In reviewing patent claims covering a “therapeutically effective” drug, which is a combination of a prior FDA-approved immediate-release drug and a well-known extended-release drug delivery system, the Federal Circuit, in reversing a district court holding of obviousness, held that such claims would not have been “obvious.” Specifically, the Federal Circuit created a “PK/ PD relationship” requirement to hold that one skilled in the art would have “no reasonable expectation of success” that the claimed drug was “therapeutically-effective” even though it was bioequivalent to the prior FDA-approved drug. The questions presented are:

Whether the Federal Circuit erred in finding the “therapeutically effective” claims not obvious under 35 U.S.C. § 103(a) for a drug that combined a prior FDA-approved immediate-release drug and a well-known extended-release drug delivery system to create a bioequivalent extended-release formulation.

Whether the court of appeals improperly relied on its newly-minted “PK/PD relationship” requirement to substitute de novo review for clear error review in order to give its finding of non-obviousness additional support.

Title 35 U.S.C. § 116 requires two or more persons who make an invention jointly to apply for any patent jointly and provides that “[i]nventors may apply for a patent jointly even though (1) they did not physically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter of every claim of the patent.” Here the patented invention is a vascular prosthesis made of a novel material. Together with his staff, the developer of the material, having overseen substantial experimentation to narrow the field of potentially useful material characteristics, made a small number of sample tubes for use as prostheses. Expecting at least one of those samples to be successful for its intended purpose - but not yet aware of the exact microscopic properties that allow success - he supplied those few samples to an experimenter who confirmed one sample's success and identified its microscopic structure.

The question presented is:

Whether it is consistent with Section 116 to deny joint-inventor status to the maker of the successful material, and instead deem the experimenter the sole inventor, on the ground that the maker did not communicate to the experimenter the exact property that turned out to be key.

Does the strong federal policy favoring settlements, including of patent disputes, outweigh the public's interest in challenges to allegedly invalid patents such that the rationale behind the holding in Lear, Inc. v. Adkins, 395 U.S. 653 (1969), which case rejected implied-at-law “licensee estoppel” defenses to patent invalidity challenges, does not mandate invalidation of “no-challenge” provisions in settlement agreements even where they are clear and unambiguous, and resolve bona fide infringement claims without litigation?

Does the Second Circuit's decision sought to be reviewed create a conflict with the most recent decisions of the Federal Circuit recognizing the enforceability of clear and unambiguous “no-challenge” provisions in agreements settling patent infringement claims prior to and in avoidance of patent invalidity litigation, and should that conflict be resolved in favor of the Federal Circuit's view that such provisions may be enforced?

To the extent that the rationale expressed 43 years ago in Lear was applied correctly by the Second Circuit, do considerations of vital public interest, including especially the strong federal policy favoring settlement, warrant reconsideration of Lear's policy articulations to the limited extent necessary to permit enforcement of clear and unambiguous “no-challenge” provisions in agreements settling bona fide patent infringement claims without litigation?

Congress has created a statutory safe harbor from patent-infringement liability for otherwise-infringing conduct that is “reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” 35 U.S.C. § 271(e)(1). In this case, the Federal Circuit concluded that this safe harbor “is limited to activities conducted to obtain pre-marketing approval of generic counterparts.” Pet. App. 27a. The question presented is:

Whether the Federal Circuit's interpretation of § 271(e)(1), which arbitrarily restricts the safe harbor to preapproval activities, is faithful to statutory text that contains no such limitation, and decisions of this Court rejecting similar efforts to impose extra-textual limitations on the statute.

The United States Court of Appeals for the Federal Circuit stepped outside the boundaries of its appellate role, as it has done with alarming frequency the past few years, and assumed the role as fact-finder in adjudicating Leader Technologies, Inc.'s patent invalid. As an intermediate federal appellate court, the Federal Circuit is not a trial court, but nonetheless acted as one in the present case and engaged in a form of decision-making at odds with traditional notions of appellate review. The proper role of an appellate court is to decide appeals from the lower court, and should do so based on the decision below and on the arguments presented by the parties below. In far too many instances, however, the Federal Circuit, as it did in this case, takes upon itself to consider evidence not argued to the lower court, disregard the fact-finding below, disregard binding precedent of this Court, and goes beyond the factual record presented to the proper trier of fact in order to engage in its own fact-finding, evidentiary weighing, and advocacy. Not only does this type of appellant court advocacy encourage litigants to retry cases at the appellate level, but more importantly, it denies litigants their due process rights.

The questions presented are:

Whether the Federal Circuit violates a litigant's procedural due process rights when it steps outside its appellant role and engages in independent fact-finding, and to what extent it can ignore Rule 52(a) in substituting its view of the factual issues for that of the district courts.

Whether the Federal Circuit can disregard Supreme Court precedent on interpretation of verb tense when applied to patent law, or alternatively, construe patent-related Supreme Court precedent in such a way to vitiate this Court's holdings.

Whether 35 U.S.C. § 112, first paragraph, which requires that the sufficiency of a patent claim's written description is to be assessed from the perspective of a person of skill in the art, nevertheless warrants, as a matter of law, excluding a disclosed embodiment within a patent, including any pertinent figure and accompanying disclosure, from the source of potential written description for the claim on the grounds that the embodiment lacks each and every feature recited in the claim.

If the subject matter of a claim is the combination of two or more disclosed embodiments that would have been obvious to one of ordinary skill in the art from the disclosed embodiments, is written description satisfied?

In Markman v. Westview Instruments, this Court afforded the power of construing the meaning of patent claim terms to judges. Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996). The justification for this Court's decision in Markman was in large part to provide uniformity and consistency to the interpretation of a patent's exclusive rights. Id. at 390-91. Unfortunately, the United States Court of Appeals for the Federal Circuit has failed in this endeavor, wreaking confusion and uncertainty on the patent system. In particular, the Federal Circuit refused to elaborate the proper standard for when and to what extent it is appropriate to limit the scope of a claim based upon the specification.

The Federal Circuit's abdication of its role is particularly salient here, where the court simply refused to consider the claim construction issue, notwithstanding inconsistent interpretations of the same patent by the Patent Examiner, the Board of Patent Appeals and Interferences, and a district court in a related litigation.

The questions thus presented are:

when and to what extent is it appropriate to narrow the scope of a patent claim based upon the specification and

has the Federal Circuit's failure to clarify the reach of the Broadest Reasonable Interpretation standard led to an unwarranted expansion of the standard's application by the Board of Patent Appeals and Interferences?

Retractable Technologies, Inc. and Thomas J. Shaw (collectively, “RTI”) have filed a petition for a writ of certiorari seeking review of the method that the United States Court of Appeals for the Federal Circuit used to construe the term “body” in patents owned by RTI. Specifically, RTI argues that the clear statements in the specification defining the “invention” as having a “one piece hollow outer body,” criticizing the “two-piece” designs in the prior art, and touting the benefits of a one-piece design were not sufficient to show that the term “body,” as used in the patent claims, refers to a one-piece body.

If RTI's petition is granted, the Court should also consider the following questions, which provide alternative grounds for affirmance:

Whether the Federal Circuit's construction of the “lodging” limitation should be reversed because, at RTI's urging, the Federal Circuit deviated from the term's clear meaning on far weaker grounds than the court relied on to construe the ambiguous term “body.”

Whether the Federal Circuit's construction of the “retainer member” limitation should be reversed because, at RTI's urging, the Federal Circuit deviated from the term's clear meaning on far weaker grounds than the court relied on to construe the ambiguous term “body.”

Whether the Federal Circuit's holding that the asserted claims cover devices that work by cutting should be reversed because, at RTI's urging, the Federal Circuit disregarded a clear disclaimer of claim scope on far weaker grounds than the court relied on to construe the ambiguous term “body.”

Whether a court may depart from the plain and ordinary meaning of a term in a patent claim based on language in the patent specification, where the patentee has neither expressly disavowed the plain meaning of the claim term nor expressly defined the term in a way that differs from its plain meaning.

Whether claim construction, including underlying factual issues that are integral to claim construction, is a purely legal question subject to de novo review on appeal.

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